Randomizing law
M Abramowicz, I Ayres, Y Listokin - U. Pa. L. Rev., 2010 - HeinOnline
Legal scholars have debated the impacts of government policy for millenia. In 81 BC,
Chinese scholars argued about the desirability of monopolies in the salt and iron industries …
Chinese scholars argued about the desirability of monopolies in the salt and iron industries …
FDA's expedited approval mechanisms for new drug products
EE Kepplinger - Biotechnology law report, 2015 - liebertpub.com
Modern medicine and science have made in-credible strides in improving and extending
lives. Nonetheless, many diseases and conditions still lack adequate therapies. According to …
lives. Nonetheless, many diseases and conditions still lack adequate therapies. According to …
Abigail Alliance For Better Access v. Von Eschenbach
495 F. 3d 695 - Court of Appeals, Dist. of Columbia Circuit, 2007 - Google 学术搜索
ABIGAIL ALLIANCE FOR BETTER ACCESS v. VON ESCHENBACH 495 F.3d 695 (2007)
ABIGAIL ALLIANCE FOR BETTER ACCESS TO DEVELOPMENTAL DRUGS and Washington …
ABIGAIL ALLIANCE FOR BETTER ACCESS TO DEVELOPMENTAL DRUGS and Washington …
Leopards in the temple: restoring scientific integrity to the commercialized research scene
T Lemmens - Journal of Law, Medicine & Ethics, 2004 - cambridge.org
Leopards break into the temple and drink to the dregs what is in the sacrificial pitchers; this
is repeated over and over again; finally it can be calculated in advance, and it becomes part …
is repeated over and over again; finally it can be calculated in advance, and it becomes part …
Regulation of Emerging Risks
MT Wansley - Vand. L. Rev., 2016 - HeinOnline
Emerging risks differ from other risks that the state regulates in two ways. The first is
epistemic: the information necessary to answer potentially dispositive questions about how …
epistemic: the information necessary to answer potentially dispositive questions about how …
[HTML][HTML] When the alpha is the omega: p-values,“substantial evidence,” and the 0.05 standard at FDA
L Kennedy-Shaffer - Food and drug law journal, 2017 - ncbi.nlm.nih.gov
A prominent feature of statistical reasoning for nearly a century, the p-value plays an
especially vital role in the clinical testing of new drugs. Over the last fifty years, the US Food …
especially vital role in the clinical testing of new drugs. Over the last fifty years, the US Food …
Reflections on historical, scientific, and legal issues relevant to designing approval pathways for generic versions of recombinant protein-based therapeutics and …
DM Dudzinski - Food & Drug LJ, 2005 - HeinOnline
As the recombinant DNA revolution swept the scientific landscape in the 1970s, it forever
altered not only molecular biology, but also university commercialization, the nascent …
altered not only molecular biology, but also university commercialization, the nascent …
Governing lipitor and lipstick: capacity, sequencing, and power in international pharmaceutical and cosmetics regulation
Over the last three decades, the pharmaceutical and cosmetics industries have become
increasingly global. To ensure product safety and consumer protection, regulators in leading …
increasingly global. To ensure product safety and consumer protection, regulators in leading …
This Is Your Products Liability Restatement on Drugs
L Noah - Brooklyn Law Review, 2009 - papers.ssrn.com
This paper attempts to offer a comprehensive evaluation of the various facets of the Products
Liability Restatement that relate to medical technologies, and it does so from a perspective …
Liability Restatement that relate to medical technologies, and it does so from a perspective …
The Prescription Drug User Fee Act: Is a Faster Food and Drug Administration Always a Better Food and Drug Administration?
JL Zelenay - Food and Drug Law Journal, 2005 - JSTOR
Responding to certain drug-related public health disasters, Congress spent the greater part
of the twentieth century increasing the amount of regulation imposed on pharma ceutical …
of the twentieth century increasing the amount of regulation imposed on pharma ceutical …